Indium Blog

RoHS Recast Includes Medical Devices

Category:
  • Indium Corporation
  • RoHS

  • Folks,

    I was at the St Guadens National Historical Park a few days ago. Augustus St Guadens  is considered by many to be America’s premiere sculptor. One of St Guadens greatest works is the Shaw Memorial . This memorial  celebrates Civil War Union Colonel Robert Shaw’s attack in the second battle of Fort Wagner with the US Army’s first regiment of African Americans.  This battle took place on July 23, 1863, 150 years ago this coming Tuesday.

    Seeing this date, reminded me that the exemption of RoHS for medical devices ends in one year from this Monday, on July 22 2014.  The original version of RoHS exempted medical devices. 

    Some critical points are:

    • RoHS II, or RoHS Recast, went into effect on January 2, 2013.
    • Medical devices (RoHS category 8) and monitoring and consumer control electronics (the consumer part of category 9) lose their exemption on July 22, 2014
    • In vitro (devices for test tube experiments) are exempt until July 2016
    • Industrial monitoring and control equipment must comply in July 2017
    • In vivo (in a living organism, e.g. pacemakers) continue to be exempt.

     

    The EU will be more strict than they were with the implementation of the original RoHS.  CE marks and process documentation will be required.  In future posts I will discuss these points in more detail.

    Cheers,

    Dr. Ron